Based on the safety review of tofacitinib in Pfizer's Oral Surveillance (1133) study, the FDA has added serious boxed warnings to all three marketed JAK inhibitors (for inflammatory diseases) and formalized the recommendation that patients should be started on a TNF inhibitor (TNFi) before trying a JAK inhibitor. These recommendations apply to tofacitinib, baricitinib and upadacitinib.
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Dr. Jack Cush reviews and discusses the news and journal reports from the past week on RheumNow.com.
Genentech announced March 4th that the US Food and Drug Administration approved tocilizumab (Actemra) for the treatment of Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD), specifically indicated for slowing the rate of decline in pulmonary function in adults S
Based on the safety review of tofacitinib in Pfizer's Oral Surveillance (1133) study, the FDA has added serious boxed warnings to all three marketed JAK inhibitors (for inflammatory diseases) and formalized the recommendation that patients should be started on a TNF inhibitor (TNFi) before trying a JAK inhibitor. These recommendations apply to tofacitinib, baricitinib and upadacitinib.
Since the start of the pandemic, hydroxychloroquine (HCQ) was forced into the limelight for the prevention/treatment of COVID-19. When it was found to be ineffective for COVID-19 and might cause potential harm, the drug came under closer scrutiny for its safety profile.
Safety comparisons of JAKi (tofacitinib) vs. TNFi from Oral Surveillance showed that, in patients with active RA on MTX and aged >50 years with one or more CV risk factors, that there was numerically more MACE events, malignancies, and VTE especially in higher dose.
The ACR 2021 meeting has concluded. Dr. Jack Cush recounts a few more great abstracts from this past week’s virtual meeting.
Early cardiovascular disease assessment and management is critical at diagnosis in patients with Rheumatoid Arthritis (RA).
Evidence suggests that RA patients are at increased risk for cognitive impairment. This is likely mediated by certain factors, including chronic inflammation and accelerated atherosclerosis. In the clinical setting, it is important to identify RA patients at increased risk for cognitive impairment.
Hitting the home stretch, day 3 presentations were big! Here are a few of my favorites: secukinumab efficacy in juvenile PsA; VEXAS - predicting poor outcomes; and the FDA Safety Update session.


